Uterine bleeding when abnormal can lead to significant anemia and can even be life-threatening. Anatomical causes such as fibroid, polyps, endometrium carcinoma or endometrium hyperplasia resulting from prolonged un-opposed oestrogens deserve specific treatments which are progestins, or surgery like curettage, endoscopic resection or hysterectomy.
Dysfunctional uterine bleeding disorders (dysfunctional or abnormal uterine bleeding, metrorrhagia and menorrhagia, hypermenorrhea) are forms of pathological bleeding that are not attributable to organic changes in the uterus (such as, e.g., endometrial carcinoma, myomas, polyps, etc.), systemic coagulation disorders, or a pathological pregnancy (e.g., ectopic pregnancy, impending abortion) [American College of Obstetricians and Gynecologists, 1982]. Such disorders are most frequent after puberty or before menopause. Treatment is medical using oestrogens and progestins. If not successful and patient does not wish to preserve fertility, hysterectomy or endometrial ablation may be performed.
Another group of patients in whom controlling abnormal uterine bleeding is a clinical challenge is patients with severe coagulation disorders. These coagulation disorders results from (i) pro-coagulant protein deficiency due to genetic defect (e.g. hemophilia or von Willebrand disease) or functional deficiency (e.g. hepatic function impairment), (2) thrombocytopenia caused by decreased bone marrow production of megakaryocytes (e.g. leukemia), splenic sequestration or increased destruction of platelets (e.g. disseminated intravascular coagulation), (3) bone marrow aplasia resulting from oncological treatments such as chemotherapy and total body irradiation, and (4) inadequate anticoagulation treatment.
These conditions are difficult to manage because bleeding can be very severe and these patients often have impaired general condition with for example immunodeficiency in leukemia or bone marrow aplasia. Specific treatment like platelet transfusion, blood transfusion and coagulation factor administration are used to attempt controlling bleeding. Oestrogens and progestins are also used with relative success and possible side effects. Inducing reversible castration by sustained administration of a GnRH agonist has also been reported to be useful in some cases for preventing severe bleeding prior to chemotherapy. Surgical intervention in these patients with altered general condition and immuno-deficiency are at risk.
Being able to medically treat patients with acute conditions such as acute phase of leukemia or treat or prevent uterine bleeding during the acute phase of iatrogenic bone marrow aplasia or treat or prevent uterine bleeding in patients under anticoagulation therapy for conditions banning the use of oestrogens and/or progestins (e.g. thrombo-embolic conditions), will meet a very significant medical need.